一种可编程植入式神经刺激系统

A Programmable and Implantable Neuro-stimulator

目的研究用于神经系统疾病的功能电刺激疗法的可编程植入式神经刺激系统。方法系统由植入体内的脉冲发生器、导线、电极,用于体外遥测/程控的控制器,个人数字助理(personal digtal assistant,PDA)和磁铁组成。对靶点神经提供脉宽、频率、幅度、工作时间、关断时间可调的电脉冲刺激。结果植入式脉冲发生器的重量为34g,尺寸小于47mm×49mm×10mm,在典型的神经刺激条件下的平均功耗为54μW,预计使用寿命在10年以上。已完成20只家兔的迷走神经刺激试验,验证了系统在长期植入中的安全性和功能性。结论研制的系统可作为植入式神经刺激动物试验研究的仪器平台,满足临床应用的基本要求。

Objective To develop a programmable and implantable neuro-stimulator for use in functional electrical stimulation therapy of neural diseases. Methods The neuro-stimulator includes pulse generator, leads and electrodes implanted in the body, controller, personal digital assistant（PDA） and magnet outside the body for telemetry/programming. It provides electrical pulse stimulation to the target nerve, with adjustable pulse parameters such as pulse width, frequency, amplitude, on time and off time. Results The implantable pulse generator weighs 34 g, with a size less than 47 mm ×49 mm × 10 mm, and average power consumption of 54 μW under typical neuro-stimulation parameters. Its expected life is over 10 years. The neuro-stimulator was validated for safety and function during long-term implantation in animal experiments of vagus nerve stimulation using 20 rabbits. Conclusion The developed neuro-stimulator can be used as an instrument platform for animal experimental studies of implantable neuro-stimulation, and fulfills the basic requirements of clinical applications.